Process Engineer III, MSAT

Resilience•West Chester, OH

1d•Hybrid

About The Position

A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. The Process Engineer III, MSAT independently owns all technical aspects of assigned technology transfers from feasibility through PPQ completion and commercial introduction, serving as the primary technical escalation point for complex process issues. This role coaches Process Engineer I/II staff and partners cross-functionally with Validation, PMO, Supply Chain, Operations, and Quality.

Requirements

Demonstrated GMP experience in a regulated pharmaceutical manufacturing environment, with ability to independently apply controlled procedures and quality standards.
Training or experience in one or more of the following applicable MSAT-relevant technology areas: programmable logic controllers, computerized systems, vision systems, aseptic/controlled environment, formulation, aseptic filling, assembly, packaging, process validation, technology transfer, change control.
Demonstrated proficiency in more than one of the following disciplines: automation/controls, prep, formulation, aseptic filling, assembly, packaging equipment, development and implementation of automated visual inspection tools, technology transfer, or validation.
Demonstrated ability to coach and mentor peers on applicable MSAT processes.
Demonstrated ability to independently lead technical troubleshooting and continuous improvement efforts.

Nice To Haves

Bachelor’s degree in engineering or related science.
4+ years of experience in a GMP or regulated pharmaceutical manufacturing or MSAT environment.
Demonstrated project management experience managing technology transfer workstreams through PPQ completion.
Experience with Six Sigma, analytical troubleshooting, or LEAN manufacturing.

Responsibilities

Independently owns all technical aspects of assigned technology transfers from feasibility through PPQ completion, ensuring process capability at each phase gate.
Leads continuous improvement workstreams across multiple assigned processes — including changeover reduction, yield improvement, OEE improvement, maintenance reliability, and waste reduction — , applying structured problem-solving (e.g., DMAIC, RCA) to drive improvements.
Authors and independently approves URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports for assigned process areas.
Independently manages engineering projects from initiation to completion, including project justification, resourcing, timelines, and capital planning input.
Coordinates and supports Manufacturing/Facility improvement initiatives that define equipment data, capabilities, utilization , and efficiencies; manages the equipment life cycle, including obsolescence planning.
Independently leads change control development and implementation, evaluating cross-functional impact and applying risk-based judgment.
Performs and maintains risk management activities for assigned processes and equipment using structured risk assessment tools.
Initiates deviations and leads complex technical investigations across multiple processes, defining CAPAs and assessing impact.
Leads complex technical troubleshooting across multiple assigned processes, developing systematic approaches to recurring issues.
Authors, reviews, and independently approves controlled documents (SOPs, Batch Records, Rework procedures) for assigned process areas.
Authors, reviews, and independently approves validation and change control documents, including master plans, protocols, and summary reports.
Leads validation activities and periodic reviews — including validation required as a result of changes to validated processes , evaluating compliance status and driving corrective actions.
Coaches and mentors Process Engineer I and II staff on technology transfer, GMP practices, and problem-solving methodology.
Independently manages external technical relationships with equipment and material suppliers, evaluating solutions and resolving issues.
Designs and delivers technical training programs for Operations, Engineering, and Maintenance.
Serves as key technical contact for regulatory inspections; participates in annual product review and biennial critical systems review.